RegWardenFDA facility compliance records
Recall

Class III — T.G. Eakin Limited

Recalling firmT.G. EAKIN, LTD.
Registered facilityT.G. EAKIN, LTD. (the firm's only registered facility)
ClassificationClass III
StatusOngoing
ReasonOn lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005.
Producteakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
Quantity35,400 cartons of 20 individually packaged seals
DistributionUS: KY
Initiated2024-08-08
Classified2024-09-25
Recall numberZ-3263-2024
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class III recall — T.G. Eakin Limited (Z-3263-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95241/

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